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Acuteventilator

by Impoex International, Ltd.

510(k) K012271

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012271 Date4 Oct 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTM
Device Class
Class II
Regulation
21 CFR Part 868.5915
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Acuteventilator is a pumping apparatus of the bellows type, adapted for artificial respiration of a distressed person having temporarily no ability to breathe by themselves. It is classified as a Ventilator, Emergency, Manual (Resuscitator) under regulation number 868.5915 and product code BTM.

The device received FDA 510(k) clearance (K012271) on October 4, 2002, following a traditional submission process. It is intended for use in emergency and anesthesiology settings, and is supplied as a manual resuscitator without AI/ML or SaMD functionality.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Acuteventilator used for?

    The Acuteventilator is a pumping apparatus of the bellows type designed for artificial respiration of a distressed person who temporarily cannot breathe on their own, intended for use in emergency and anesthesiology settings as a manual resuscitator.

  • How is the Acuteventilator supplied and is it reusable?

    The Acuteventilator is supplied as a manual resuscitator without AI/ML or SaMD functionality; as a bellows-type manual ventilator, it is intended for single-patient use in emergency scenarios and is not designed for reuse due to contamination risks and lack of reprocessing instructions in the provided data.

  • What regulatory pathway was used for the Acuteventilator’s clearance?

    The Acuteventilator received FDA 510(k) clearance through a traditional submission process, with clearance granted on October 4, 2002, under K012271, based on a determination of substantial equivalence to a legally marketed predicate device.